Personal Injury Law

FDA issues Early Warning on Singulair and Suicides

By Jane Akre

  IMAGE:  Cat allergies are one that Singulair is taken to counteract

Singular is used by millions of Americans who suffer from allergies.  The FDA says it may be also used by some who are considering suicide.

The Food and Drug Administration (FDA) announced it is reviewing a number of reports after three or four patients experienced mood changes that led to suicides and suicidal behavior.

Drug maker Merck says Singulair is its best selling drug at $4.3 billion in sales last year. The drug has been used by millions since its 1998 release to treat allergies and asthma.

Merck stresses that none of the 11,000 patients enrolled in their drug trials has committed suicide and the FDA says this is just an effort to inform the public, no casual relationship has been established between the drug and suicide.

If you are taking Singulair under doctors' orders you should not stop says a statement by the FDA.  But your doctor needs to monitor you for suicidal behavior or mood change.

The FDA is asking Merck to look into its data bank for any evidence of suicidal patients. The drug maker has updated its label several times over the last year to increase its warning of suicidal thinking and behavior, despite the fact that it has not determined any link to the drug's use.

The label now reads: "The following additional adverse reactions have been reported in post-marketing use: Psychiatric disorders: agitation including aggressive behavior, anxiousness, dream abnormalities and hallucinations, depression, insomnia, irritability, restlessness, suicidal thinking and behavior (including suicide), tremor."

But Merck stresses the label changes follow anecdotal reports from consumers, not data that the company has observed.

For asthma patients side effects include headache, flu abdominal pain and cough.

And many children are prescribed Singulair.

One doctor told ABC News "We have hundreds of children on Singulair and have never heard parents make complaints about psychiatric side effects," said Leslie Hendeles, professor of pharmacy and pediatrics at the University of Florida Colleges of Pharmacy and Medicine. "Moreover, there is no mechanism for this reaction . We will be telling our patients not to worry about this."

But an Albany, New York area couple is blaming their 15-year-old's death last August on his switch to Singulair from Allegra.

In an effort to have an "Early Communication" with the public about any safety concerns, the FDA is acting more quickly to notify the public before they draw any conclusions.

That is in response to criticism that the FDA acted too slowly in informing the public about another Merck medication, Vioxx, which was taken off the market after it was linked to heart attacks, or GlaxoSmithKline's troubled diabetes pill Avandia. #

Full post as published by InjuryBoard on March 27, 2008 (boomark / email).